1. Field of the Invention
The invention is directed to formulations comprised of multiple dietary and endogenous antioxidants and B-vitamins for the prevention and treatment coronary artery diseases, and pulmonary and heart diseases and disorders.
2. Description of the Related Art
Coronary artery disease (CAD) remains the number one cause of death in the U.S.A. About 1.5 million new cases are detected annually, and approximately 1 million people die of this disease every year. The current estimate is that about 62 million Americans have one or more types of cardiovascular disease, and about 14 million per year suffer from heart attack or angina. The direct and indirect cost in the U.S.A. of this disease is estimated to be about 329 billion dollars annually.
Various organizations and health professional have proposed primary prevention strategies that involve changes in the diet and lifestyle. Although these recommendations appear rational, they have not had any significant impact in reducing the risk of heart disease. This may be due to the fact that most people do not follow lifestyle changes and diet modifications, and those who do follow them do not start until atherosclerosis is well established. At present, statin with or without niacin is recommended to patients with high LDL-cholesterol and low HDL-cholesterol, and aspirin for the primary prevention as well as treatment of CAD. However, some patients at high cholesterol-lowering drug doses may exhibit muscle pain and liver toxicity, and a significant number of these patients develop varying degrees of aspirin resistance. Therefore, the current strategy for the prevention and treatment of CAD needs improvement.
Since increased oxidative stress and homocysteine level are considered major risk factors in the etiology of CAD, it appears rational to suggest that daily supplementation with multiple dietary and endogenously made antioxidants together with B-vitamins may enhance the efficacy of the current strategies for the prevention and treatment of CAD. Although the U.S. Prevention Service Task Force recommends vitamin supplements to reduce the risk of cancer and CAD, the role of antioxidants alone or in combination with standard therapy in the prevention or treatment of CAD has become a controversial and confusing issue for the public as well as professionals. This is due to the fact that interventional trials with dietary antioxidants, mostly with vitamin E alone or in combination with cholesterol-lowering drugs, have produced inconsistent results, varying from a beneficial effect to no effect to a harmful effect.
A few excellent reviews have summarized the published data on these issues, but did not identify possible reasons for inconsistent results of interventional trials with antioxidants, and did not propose any specific recommendations for the prevention or as adjunct to standard therapy the treatment of CAD. Based on the current inconsistent results of intervention studies, it is inappropriate to promote the notion that antioxidants have no value in the prevention or treatment of CAD or that they may have adverse effects in CAD patients taking statins and/or niacin.